Senior Manager, R&D Quality Analytics – Portfolio Insights

🔥 1 hour ago

🌐 Switzerland, United Kingdom, +1 more countries – Remote

🇨🇭 Switzerland – Remote 🇬🇧 United Kingdom – Remote 🇩🇪 Germany – Remote

💵 CHF141.8k - CHF177.3k / year

⏰ Full Time

🟠 Senior

📉 Data Analyst

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BeOne Medicines

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 2010

🧬 Biotechnology

🏥 Healthcare

💊 Pharmaceuticals

Biotechnology • Healthcare • Pharmaceuticals

BeOne Medicines is a global oncology company domiciled in Switzerland that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a portfolio spanning hematology and solid tumors, BeOne is expediting the development of its diverse pipeline of novel therapeutics through its internal capabilities and collaborations. With a growing global team of more than 11,000 colleagues spanning six continents, the Company is committed to radically improving access to medicines for far more patients who need them.

📋 Description

• Partner with R&D Quality leadership and GCP, GVP, GLP, and GCLP stakeholders to identify quality questions, emerging risks, oversight gaps, and intervention opportunities • Conduct cross-study, cross-program, cross-vendor, and cross-process analyses to identify recurring, systemic, and portfolio-level risks • Develop and maintain quality indicators, critical-to-quality factors, quality tolerance limits, risk indicators, thresholds, escalation criteria, and portfolio surveillance methods • Integrate and analyze clinical, safety, pharmacovigilance, laboratory, monitoring, audit, inspection, vendor, system, and quality data • Develop analytics for audit planning, patient-safety and subject-protection risk detection, GLP/GCLP oversight, and GVP oversight • Design, develop, test, implement, and maintain statistical packages, analytical applications, dashboards, automated workflows, predictive models, and decision-support tools • Perform data profiling, mapping, cleaning, transformation, source-to-report reconciliation, and root-cause analysis • Govern analytical and AI-enabled solutions through intended-use documentation, data lineage, testing, validation or assurance, access controls, version control, change management, human review, explainability, performance monitoring, and retirement planning • Create executive-ready visualizations, quality narratives, risk summaries, and actionable recommendations • Support Quality Management Review, portfolio quality surveillance, RBQM governance, audit planning, inspection readiness, vendor oversight, computerized-system oversight, and continuous improvement • Partner with Clinical Operations, Clinical Development, Data Management, Biometrics, Medical Monitoring, Pharmacovigilance, Regulatory Affairs, laboratory, RBQM, audit, technology, data engineering, and platform teams • Lead or coordinate analytics workstreams from problem framing through development, testing, implementation, adoption, monitoring, and benefit realization • Stay current with R&D regulatory expectations, industry practices, statistical methods, responsible AI principles, and emerging technologies

🎯 Requirements

• Experience in pharmaceutical, biotechnology, clinical research, healthcare, or another regulated life-sciences environment • Demonstrated knowledge of R&D Quality, clinical quality, quality assurance, compliance, risk management, or regulated research and development operations • Strong working knowledge of GCP and ICH requirements • Familiarity or experience in GVP, GLP, GCLP, data integrity, computerized-system assurance, and global R&D Quality expectations • Experience with structured and unstructured data, data mapping, data cleaning, reconciliation, transformation, data modeling, automated quality checks, and data pipelines • Experience applying statistical analysis, central statistical monitoring, anomaly detection, forecasting, predictive modeling, machine learning, natural-language processing, generative AI, or related methods to clinical, safety, research, or quality problems • Ability to translate complex R&D Quality and operational processes into scalable technical solutions • Ability to communicate technical findings clearly to nontechnical stakeholders and convert analyses into actionable quality recommendations • Advanced proficiency with SQL and hands-on proficiency with R or Python • Experience with Power BI or comparable visualization and business-intelligence platforms • Experience with statistical programming, central monitoring, anomaly detection, predictive modeling, or machine-learning tools and methods • Experience with APIs, data warehouses, cloud platforms, ETL/ELT workflows, Git or comparable version-control tools, and analytical development environments • Experience with automation, natural-language processing, generative AI, or model deployment and monitoring tools is preferred • Proficiency with Microsoft Office applications • Excellent written, verbal, presentation, and interpersonal communication skills • Ability to collaborate across global, cross-functional, clinical, safety, research, quality, data, and technical teams • Ability to work with sensitive or confidential clinical, safety, quality, laboratory, and patient-level information in accordance with applicable requirements • No direct people-management responsibility is required; may provide technical leadership, coaching, and work direction • May require up to 20% travel

🏖️ Benefits

• May require up to 20% travel • Equal opportunity employment • Opportunity to work for a global oncology company • Collaboration with a global team spanning six continents